Frequently asked questions

You may have some questions about the BEACON-CF clinical research study or clinical research studies in general. Here, you can read some frequently asked questions and the answers. Your study doctor or the clinical research study team will be able to answer any further questions that you may have.

What is a clinical
research study?

Clinical research studies involve testing investigational study drugs on people living with a particular condition. All investigational study drugs have to be tested before they are allowed to be used in medical care. To begin with, investigational study drugs are tested in a laboratory on animals. Later, clinical research studies take place to understand how these investigational study drugs can affect people. The BEACON-CF clinical research study is taking place in people.

What does
“investigational” mean?

The study drug in this clinical research study is called investigational because it is not yet approved for treating cystic fibrosis by health authorities, such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) in the European Union, or health authorities in other countries. The BEACON-CF clinical research study will help researchers to understand how safe the investigational study drug is, and how it may help the treatment of cystic fibrosis for the future.

Is it safe to take part in a clinical research study?

All clinical research studies must be reviewed by regulatory authorities to make sure everyone who chooses to take part is treated safely and fairly. This review is carried out by health authorities and groups called institutional review boards and research ethics boards, which are external groups that are not affiliated with any clinical research studies. This means the review is as unbiased as possible, and helps make sure all clinical research studies uphold the same safety and ethical standards.

Without this review, clinical research studies would not be able to take place. There may be risks in taking part, either from the investigational study drug or device, or the tests involved, and these are explained in detail by the study doctor before you decide to take part. You will always have the option to ask questions about any of the tests or procedures involved in the study, and you can stop taking part in the study at any time.

Where do clinical research studies take place?

Clinical research studies can take place in many locations, including hospitals, universities, doctors’ offices, and community clinics.

If you are interested in the BEACON-CF clinical research study, click here to find out where it is taking place near you.

How much of my time will this clinical research study take up?

If you meet the criteria and decide to take part, the study doctor will share more information about the number of visits and the time expected from you during the study.

There are two parts to the study — Part 1 takes about 28 weeks, and Part 2 takes about 32-36 weeks. If you participate in both parts, you can expect to be in the study for up to about 64 weeks in total.

How many people will be taking part in the BEACON-CF clinical research study?

Approximately 36 people will take part in this clinical research study. Additional people may also be able to take part.

What are my responsibilities if I take part?

Your responsibilities for the BEACON-CF clinical research study will be explained to you by your clinical research study team. Some of your responsibilities will include:

Attending all clinical research study appointments as scheduled and complying with the study procedures and tests. Please note that you will need to stay in the hospital overnight for some of your appointments.
Telling the study doctor about your current medical condition(s), medical history, and letting your study doctor know about any prescription, over-the-counter, or herbal supplements you are taking or have taken recently.
Telling your study doctor immediately if you begin to feel unwell or experience any side effects, even if you do not think it is related to the clinical research study.
Letting your study doctor know if you change address or phone number, so they can stay in contact with you during the clinical research study.

Are there any risks from taking part in this clinical research study?

There are some possible risks to taking part, which may occur from the investigational study drug or investigational device, or from some of the tests. Before taking part, you will be provided with an Informed Consent Form that describes the full details of the risks involved. The study doctor will also discuss risks with you and will answer any questions that you may have about the clinical research study.

Are there any benefits from taking part in this clinical research study?

It is not expected that you will experience a direct benefit due to participating in this clinical research study. However, the information from this clinical research study will help to advance the knowledge of cystic fibrosis and how it is treated, and may help people living with cystic fibrosis in the future.

Can I stop taking part in the clinical research study once I’ve started?

You can stop participating in the BEACON-CF clinical research study at any time by informing your study doctor, this is called the right to withdraw. The study doctor may also stop you from taking part at any time for various reasons. Before taking part, you will receive an Informed Consent Form which provides further details on your right to withdraw.

Will I get paid to take part?

You will be compensated for your study-related time and reimbursed for expenses needed to participate in the clinical research study, like transportation, accommodation, and meals. You will be given full details as to how much you will be reimbursed by a member of the study team.